510(k) · Cleared
ClearedmyAir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed Corp · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Apr 8, 2026 as substantially equivalent to K132371 (Resmed, Ltd., 2013) after a 292-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Apr 8, 2026
- Review
- 292 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K971260 (1997). 50 ancestors in all, the oldest K914085 (1991). No later device cites it as a predicate yet.
- Root · 10 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 6 generations between
- 3 generations backK093684 Easycare OnlineResmed, Ltd. · 2010
- 2 generations backK123557 Easycare OnlineResmed, Ltd. · 2013
- 1 generation backK132371 Easycare OnlineResmed, Ltd. · 2013
- This deviceK251889 myAirResmed Corp · 2026
Show all 10 generations
- Root · 10 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 9 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 8 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 7 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 6 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 5 generations backK050775 ResscanResmed, Ltd. · 2005
- 4 generations backK082983 Resscan-ProResmed, Ltd. · 2009
- 3 generations backK093684 Easycare OnlineResmed, Ltd. · 2010
- 2 generations backK123557 Easycare OnlineResmed, Ltd. · 2013
- 1 generation backK132371 Easycare OnlineResmed, Ltd. · 2013
- This deviceK251889 myAirResmed Corp · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −9 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −8 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −7 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −6 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −5 | K050775 | Resscan | Resmed, Ltd. | 2005 | — |
| −4 | K082983 | Resscan-Pro | Resmed, Ltd. | 2009 | — |
| −3 | K093684 | Easycare Online | Resmed, Ltd. | 2010 | — |
| −2 | K123557 | Easycare Online | Resmed, Ltd. | 2013 | — |
| −1 | K132371 | Easycare Online | Resmed, Ltd. | 2013 | — |
| 0 (this device) | K251889 | myAir | Resmed Corp | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MNS device
- #1 K251661 Mariana Minerva; Mariana Nimbusscore 14.2 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 50 ancestors have a recall of any class.
- 3 other devices also cite its predicate K132371.
How does its category compare?
All MNS devicesMNS Ventilator, Continuous, Non-Life-Supporting: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MNS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MNS
115in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNS
1in 2008
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MNS
1,790in 2025
MAUDE reports naming product code MNS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 90 | 2 | 9 |
| 2008 | 0 | — | 1 | 7 |
| 2009 | 4 | 92 | 0 | 8 |
| 2010 | 4 | 124 | 0 | 9 |
| 2011 | 3 | 140 | 0 | 9 |
| 2012 | 5 | 111 | 0 | 12 |
| 2013 | 3 | 115 | 0 | 18 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 50 |
| 2016 | 2 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 20 |
| 2018 | 1 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 275 |
| 2020 | 0 | — | 0 | 64 |
| 2021 | 0 | — | 0 | 256 |
| 2022 | 1 | — | 0 | 2,514 |
| 2023 | 1 | — | 0 | 1,320 |
| 2024 | 1 | — | 0 | 1,571 |
| 2025 | 0 | — | 0 | 1,790 |
| 2026 | 3 | 269 | 1 (1) | — |
What is it indicated for?
The myAir app is indicated for patients: » prescribed with a compatible ResMed Airl1 PAP or NIV device to simulate therapy prior to using their device with their prescribed settings. » prescribed with a compatible ResMed Airl1 PAP device to configure their settings to support therapy. It is an optional software accessory to allow patients to acclimate and operate their therapy device. » prescribed a NightOwl wearable device to provide the user interface…
Read the full statement (126 words)
The myAir app is indicated for patients:
» prescribed with a compatible ResMed Airl1 PAP or NIV device to simulate therapy prior to using their device with their prescribed settings.
» prescribed with a compatible ResMed Airl1 PAP device to configure their settings to support therapy. It is an optional software accessory to allow patients to acclimate and operate their therapy device.
» prescribed a NightOwl wearable device to provide the user interface to operate the connected device and aid in the home sleep testing process.
The device is intended for home and hospital use for:
* new and existing patients of ResMed Airl0 and Airl1 PAP and NIV therapy devices and
* new users who are prescribed a compatible NightOwl home sleep apnea test (HSAT).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251889 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251889: myAir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251889
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026